Repaglinide Accord

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repaglinide

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Repaglinide Accord. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Repaglinide Accord.

This EPAR was last updated on 30/09/2020

Authorisation details

Product details
Name
Repaglinide Accord
Agency product number
EMEA/H/C/002318
Active substance
repaglinide
International non-proprietary name (INN) or common name
repaglinide
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BX02
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
22/12/2011
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

21/08/2020 Repaglinide Accord - EMEA/H/C/002318 - IAIN/0014/G

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.

Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

Assessment history

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